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临床试验/NCT02815384
NCT02815384Unknown不适用

Assessment Of MRI In Patients With Implanted Cardiac Devices

University of Arizona1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年10月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
Safety of MRI, adverse clinical events

研究概览

简要总结

The research goal is to continue to add to the extensive body of peer-reviewed evidence that demonstrates MRI may be safely performed in patients with cIEDs, after they have been evaluated and cleared by cardiology. This study will allow the researchers to collect data from the facilities ongoing clinical practice regarding the number and types of any adverse clinical reactions, and also to document any changes in the implanted cardiac device that may have occurred during the MRI scan. The researchers will also be assessing the results of the MRI and how the imaging findings impact patient care and the clinical outcome of the patient. This data will then be presented to the FDA and the Centers for Medicare and Medicaid Services to further influence federal guidelines and payment structures.

详细描述

Cardiac implantable electronic devices (cIEDs) generally refer to implanted pacemakers and defibrillators for patients with cardiac disorders affecting their heart rhythm. Previously, cIEDs have been regarded as a contraindication to magnetic resonance imaging (MRI) scans, with concerns that the magnetic fields of the MRI may cause problems with the patient's cIED. However, this is a major healthcare issue, as approximately 50-75% of patients with implanted cIEDs are expected to need a future MRI as part of their clinical care. The inability to get such a test may negatively impact the ability to diagnose and treat future diseases.

However, many of the initial concerns regarding the capability of performing MRI in patients with cIED have likely been overstated. There is peer-reviewed literature dating back to the 1990s regarding the ability to safely perform MRI in patients with cIEDs, if certain protocols are followed regarding patient selection and monitoring. In 2011, Nazarian et al from Johns Hopkins University published a study on 438 patients with cIED that received MRI. There were no adverse clinical effects from this study. In fact, the American College of Radiology updated it's guidance document for Safe MR Practices, and cIEDs are no longer listed as a relative contraindication to obtaining an MRI. However, the presence of cIEDs are still regarded as a relative contraindication to performing MRI at some centers. In addition, performance of MRI in the setting of cIED is denied by the Centers for Medicare and Medicaid Services. Continued accrual of data regarding the safety of performing MRI in patients with cIEDs is needed, including outcomes studies that document the clinical impact of improved diagnostics provided by the MRI on patient care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .

排除标准

  • patient does not require an MRI for their medical care
  • patient does not have a cIED
  • patient has not been seen or approved by cardiology to be a candidate for MRI
  • patients under the age of 18
  • pregnant patients
  • prisoners

结局指标

主要结局

Safety of MRI, adverse clinical events

时间窗: immediately post MRI

collect safety data

次要结局

  • Morbidity, Number of hospitalizations(6 months)
  • Impact to Patient Care(6 months)
  • Mortality, outcome of death(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bobby Kalb, MD

MD

University of Arizona

研究点 (1)

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